The FDA conducted an inspection of a manufacturing facility located in the US and found significant violations of Current Good Manufacturing Practice (CGMP) regulations.
The violations identified include the following:
- The firm released batches of Sunscreen Drops SPF32 without adequate testing of the active ingredients, zinc oxide, and titanium dioxide.
- The firm used food-grade titanium dioxide without ensuring it conformed to United States Pharmacopeia (USP) specifications.
- Failure to establish adequate written procedures for production and process control, including process validation, equipment qualification, cleaning validation, and batch production records.
- Failure of the quality control unit (QU) to ensure compliance with CGMP and meet established specifications. There was also a lack of traceability for finished drug products.
The FDA requested the following actions in response to the identified violations:
- Comprehensive assessment and remediation plan for laboratory practices, procedures, methods, equipment, documentation, and analyst competencies.
- List of chemical and microbial specifications, including test methods, for analyzing each batch of drug products and an action plan for conducting full chemical and microbiological testing of retain samples.
- Comprehensive review of the material system, including qualification of suppliers and incoming material controls.
- Detailed validation program for process control, equipment qualification, and facility qualification, including protocols and procedures.
- Master production and control records for drug products and procedures to ensure completion and review of production records by the quality unit.
- Improvements to the cleaning validation program, incorporating worst-case conditions.
- Comprehensive assessment and remediation plan to ensure the effectiveness of the QU, including oversight, review of each batch, and approval of investigations.
- Implementation of quality systems and risk management approaches in compliance with CGMP regulations.
Recommendation: The firm should consideration of engaging a qualified consultant to assist in meeting CGMP requirements.
Read also: FDA Findings and Remdies on cGMP Violations
Resource Person: Kieran Falvey, PMP